Why Patients Decline or Are Being Deemed Ineligible to Receive Home-based Treatment: a Mixed Methods Study

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorOdense University Hospital

About this trial

Treatment for blood cancers has improved significantly, and more patients are now living longer. However, these treatments are often intensive and long-lasting, and many patients experience serious side effects and symptoms. As more patients require ongoing treatment and long-term care, the demand for haematology services is increasing.

Home-based treatment is expected to play an increasingly important role in the future. It can support more patient-centred care, help patients maintain their everyday lives, improve quality of life, and reduce pressure on hospitals. Despite these benefits, some patients are either not eligible for home-based treatment or choose to decline it. The reasons for this are not yet well understood.

This study combines quantitative data-such as medical information, sociodemographic characteristics, and questionnaire responses about quality of life and health literacy-with qualitative interviews involving patients, relatives, and healthcare professionals. The aim is to identify barriers and differences between patients, and to better understand why some patients opt out of or are unable to participate in home-based treatment.

The findings will help support the development of more inclusive and patient-centred care models, ensure more equal access to home-based treatment, and improve support for socially vulnerable patients. The results will be shared with patients and families through patient organisations, with hospitals through the Treat@Home programme, and at national and international conferences.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

>=18 years old

diagnosed Multiple Myeloma or acute leukemia, and recieving treatment with either Daratumumab or Cytarabine.

Disqualifiers

None

Trial population

All patients from the Department of Hematology at Odense University Hospital and Zealand University Hospital who are enrolled in the two Treat@Home studies will be invited to participate, including those who accept, decline, or are deemed ineligible for home-based treatment. We aim to include 50 participants, with 25 recruited from each site.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

50 Participants
are grouped into 3 trial groups
Group A: Patients enrolled in a Treat@Home study
Group B: Patients declining enrollment in a Treat@Home study
Group C: Patients deemed not eligible for enrollment in a Treat@Home study

Trial outcomes

Primary outcomes

1

Perceptions - patient

Semi-structured interviews with patients at inclusion

Time frame
Day 1
2

Perception - caregivers

Semi-structured interviews with caregiver (together with patient) at inclusion

Time frame
Day 1
3

Perception - Healthcare staff

Focus group interview with Healthcare staff at end of study (after inclusion of all patients) in regards to barriers and possibilities in home administration

Time frame
At study completion (end of inclusion of all patients)

Secondary outcomes

1

Biological sex

male, female

Time frame
Day 1
2

Patient reported outcomes

Health literacy was assessed using the Health Literacy Questionnaire (HLQ), which contains multiple domains scored on separate scales, with higher scores indicating better health literacy.

Time frame
Day 1
3

Patient Reported Outcome

Quality of life was assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30; scores range from 0-100, with higher functional and global health scores indicating better quality of life and higher symptom scores indicating greater symptom burden).

Time frame
Day 1
4

Caregiver burden

Caregiver burden was assessed using the Caregiver Roles and Responsibilities Scale (CRRS), with higher scores indicating greater caregiver burden.

Time frame
Day 1

Other outcomes

Sponsors and contacts

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